Pharmaceutical Sector Country Profile Questionnaire
ETHIOPIA
The Pharmaceutical Sector Country Profile Survey
1. Background and Rationale: Pharmaceutical Sector Country Profiles aim to increase the availability of quality information on structures, processes and outcomes of health and pharmaceutical sectors of countries. This information will be collected through a questionnaire and is meant to be used by country decision-makers, health and pharmaceutical experts, international partners and the public through databases and published country, regional and global reports. The information is categorized in nine sections, namely: (1) Health and Demographic data, (2) Health Services, (3) Medicines Policies, (4) Medicines Trade and Production, (5) Medicines Regulation, (6) Medicines Financing, (7) Pharmaceutical Procurement and distribution, (8) Selection and Rational Use and (9) Household data/access. Every four years since 1999, health officials from the 193 WHO Member States have been invited to complete a standardized questionnaire (named Level I) reporting on the status of the national pharmaceutical situation. Level I indicators assessed structures and processes related to the pharmaceutical situation of a country. They were used to carry out a rapid assessment that would highlight strengths and weaknesses of countries pharmaceutical situations. 156 countries responded to the 2007 level I survey and the results were stored and available in a global WHO database and used to develop a global report as well as a number of regional and sub-regional reports. The Pharmaceutical Sector Country Profile questionnaire described here will replace the Level I tool for the 2011 Member States' survey. The aim of this new approach is to build on the achievements and lessons learnt from the Level I tools and surveys and to improve the quality and scope of information (e.g, outcomes and results indicators) and enhance the involvement and ownership of countries in the development of profiles. The new tool has been piloted in the 15 countries of the Southern African Development Community in 2009 and in 13 countries across the world in 2010. The results
of
these
pilots
are
available
on-line
at:
http://www.who.int/medicines/areas/coordination/coordination_assessment/en/index.html Another innovation of the 2011 survey is the collaboration between WHO and The Global Fund. In 2009, the Global Fund developed and introduced the Pharmaceutical and Health Product Management ("PHPM") Country Profile to gradually replace the Procurement and Supply Management ("PSM") Plan. In the course of 2010 both agencies have developed a joint Pharmaceutical Sector Country Profile questionnaire that includes key indicators of the Pharmaceutical Sector Country Profile Questionnaire. Final Version.
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pharmaceutical sector and that will be used by both agencies as the sole tool for pharmaceutical sector data collection in countries. The information captured in the Pharmaceutical Sector Country Profile questionnaire will be used by the Global Fund during grant negotiations and signing, and will also support grant implementation. In addition to the Country Profile that provides an overview of countries' pharmaceutical sectors, the Global Fund will also use a second questionnaire that will focus in more detail on medicines procurement and supply.
2. What can Pharmaceutical Sector Country Profiles offer: Completing this questionnaire will require the time of national experts and responsible officers but it is worthwhile as your country and your partners will benefit from it in a number of ways: I) The questionnaire offers a unique opportunity to consolidate, in one place, information that is available in different locations and institutions e.g. the National Medicines Regulatory Authority, Central Medical Stores, National Health Accounts, etc. II) The methodology proposed for filling in the questionnaire will ensure that good quality data are collected and that the source and date of information are known and reported. III) Data on structure, process and outcomes are collected, and the questionnaire has been pre-filled with data available in the public domain; indicators are divided into core and supplementary in order to make it easier to identify what is more important. IV) The data collected will highlight the strengths and weaknesses of the pharmaceutical sector and will be made available in a national database as official country information, for use by decision-makers, health and pharmaceutical experts, researchers and international partners and the public.. V) The data collected could be transformed into a narrative report with robust data analysis and bibliographic references, that will summarize the medicines situation in the country. VI) Based on experiences from previous surveys, a detailed glossary of key definitions and a manual for use of the questionnaire have been developed and can be found at the end of the questionnaire.
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3. The process of data collection and analysis: 3.1 Data collection. The Pharmaceutical Sector Country Profile questionnaire has already been filled in by WHO with reliable data available from global and country sources. We kindly ask you to review, to correct (if necessary) and to validate the information already included in the questionnaire, and also to fill in the gaps, based on reliable information available in your country. In order to do this, we recommend that you involve the most appropriate respondents and responsible institutions to fill in the various components of the tool so that the questionnaire is completed within the given deadline, with good quality information. If during the data collection process, clarifications are needed, WHO Regional and Headquarters Offices will provide the necessary assistance and support, including for data quality issues. 3.2 Official endorsement. Once the questionnaire has been completed, the information contained in it should be officially endorsed and its disclosure authorized by a senior official in the Ministry of Health. This should be done by signing the formal endorsement form attached to the questionnaire. This will ensure that the quality of the information contained in the Pharmaceutical Sector Country Profile questionnaire is certified by the country. 3.3 Data shared with the Global Fund. Data collected from Global Fund priority countries will be shared with the Global Fund and it will be used as part of the Global Fund's own grant signing and implementation procedures. 3.4 Data posted on key databases. Data endorsed by the country will be posted on health databases (such as the WHO
Global
Health
Observatory,
http://www.who.int/gho/en/), making it available to decision-makers, health and medicines experts and researchers, international partners and the public.
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3.5 Development of narrative Pharmaceutical Sector Country Profiles. Data provided within the country questionnaire can be used by the country to develop a narrative profile that will illustrate the national pharmaceutical sector. In order to do this, WHO has prepared a template profile (included in the CD-Rom shared with you) that can be easily used by countries and that will help presenting data in the form of tables, graphs and charts. Countries could seek support from WHO for the development of their narrative profile, which will be finalized and validated by the country that will own the copyright for it and will publish it as a national official document. 3.6 Development of Regional and Global Reports. The information provided by countries in the Pharmaceutical Sector Country Profile questionnaire will be analysed by WHO and used to produce regional and global reports on the pharmaceutical sector of countries in 2011. These reports will provide an overview of the progress made between 2007 and 2011, of the challenges that remain to be addressed and will include data analysis by technical areas, countries' income level and geographical location.
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Guidelines for countries on how to fill in the Pharmaceutical Sector Country Profile Questionnaire Please read these instructions carefully before starting data collection
1. Macros: the questionnaire has macros installed. A macro is a series of MS Word commands and instructions that are grouped together as a single command to accomplish a task automatically. For these macros to work properly, the macro security levels for MS Word on your computer should be set as 'low'. This can be easily adjusted by taking the following steps: 1. Open the Word document containing the instrument. 2. Go to 'Tools' > 'Macro' > 'Security'. 3. Click on the tab 'Security Level'. 4. Set the Security on 'Low' and click 'OK'. After filling in the questionnaire, the setting should be restored to a higher level of security in order to protect your computer. 2. Core and supplementary indicators: the instrument consists of core and supplementary questions. Core questions cover the most important information, while supplementary questions deal with more specific information applicable to particular sections. Please note that core questions have been shaded with different coloured backgrounds for different sections of the instrument, while supplementary questions are all white. This should help you to distinguish between the different categories of indicators. Please try to fill in all the core questions for each section before moving to the supplementary ones. Remember that we are only asking you to collect information that is already available and you are not expected to conduct any additional survey(s). 3. Prefilled data: the answers to some of the questions have been prefilled by WHO HQ. Where this is the case, please verify this information as it may not be up-to-date. If you find that any of the prefilled responses are not correct, please change the value and document the source and year.
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4. Calculated fields: for a few items, you will not be required to enter any value as these will be generated at WHO HQ using data entered into related fields. These fields have been clearly marked in red – please do not input any data into them or change data that are already in this field. For example, the per capita expenditure on health will be automatically calculated once the total health expenditure and population are entered into the questionnaire. This system is intended to improve the quality of answers and avoid you having to perform additional calculations. Calculated fields are protected and cannot be changed.
5. Possible answers: Checkbox 'Yes/No/Unknown': tick one of the three options (only one answer is possible). Multiple choice checkbox: tick any of the options that apply (multiple answers are sometimes possible). Percentage fields: 0-100. Please use decimal points ('dots') for decimals (example: 98.11). Please do not use ranges (e.g. "3-5"). If you only have ranges, then use the median and otherwise the mean. In this instance, please detail what data you have used and what the range is in the comment boxes. Number fields: unlimited number. Please use decimal points ('dots') for decimals (example: 29387.93). Please do not use ranges. If you only have ranges, then use the median and otherwise the mean. In this instance, please detail what data you have used and what the range is in the comment boxes. 6. Comments: comments fields allow the entry of free text to clarify or follow up on answers given. Please reference each comment by using the number of the question you are referring to (example: 2.01.02). 7. Year of data : year fields should be used to specify the year of the data used to answer the question. Only values between 1930 and 2011 will be accepted. Please use this column as follows: -
When the source refers directly to a specific document (for example: 'Medicines Act' or 'EML'), please put in the publication year of the document (note: only the year and not a specific date can be entered).
-
When the source refers to a document that contains older data than the document itself, please put in the original year of the data. For example, when the total population for 2008 is extracted from the World Health Statistics 2010, please put 2008 in the 'year' column and 'World Health Statistics 2010' in the 'source' column.
-
When the source of the information is not a document, but the informant himself/herself, please put in the current year.
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8. Source of data: sources used for the answers given will be referenced in the narrative country profile and in the databases in which the information will be stored. Please specify your sources as clearly as possible by providing the name, year, and writer/publisher of the documents used. Also provide a web (URL) link to the documents, if available. If there is only a non-English version of the reference available, then please include it regardless of the language. Use the 'source' column to enter the name and year of the source, and use the "Comments and References" fields at the end of every section to list the sources. In case the source is not documented, then provide the name and title of the person and/or the entity they work for as a source of information. Examples are given below.
9. Documents: you will see in the questionnaire that we would like you to collect and share a number of key country documents that we believe would greatly enrich the country’s profile content and these documents could be made available through countries and WHO web pages. Please attach the following documents, if available: -
National Medicines Policy (NMP);
-
NMP implementation plan;
-
National Medicines Act;
-
National pharmaceutical Human Resources report or strategic plan;
-
Latest report on the national pharmaceutical market (any source);
-
Pharmacovigilance national centre report (including an Adverse Drug Reaction (ADR), analysis report produced in the last two years);
-
National pharmaceutical legislation or regulation;
-
Annual report of quality control laboratories;
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-
Annual report of national regulatory authority;
-
Legal provisions on medicines price regulations;
-
Medicines procurement policy;
-
National Essential Medicines List (EML);
-
National Standard Treatment Guidelines (STGs);
-
National strategy for antimicrobial resistance;
-
Any other medicines pricing/availability surveys, household surveys and rational use surveys, in addition to the ones used to prefill the instrument.
The last page of the questionnaire contains a table with the list of key documents to be attached. Please fill it in by indicating the exact title, publisher and year for each attachment as shown in the example below.
Document
Exact title
Author
Publisher
Year
File name
2009
EML.doc
2005
NDP.pdf
National
Ministry of
Ministry of
Medicines List
Health
Health
National Medicines
National Drug
Federal Ministry
Federal Ministry
Policy
Policy
of Health
of Health
Essential Medicines List
These documents will be published on the WHO web site's medicines library (http://apps.who.int/medicinedocs/en/ ) and will therefore have to be endorsed by the Ministry of Health prior to being made publicly available. You can send us these documents by e-mail as attachments or you can upload them into a protected web site. Please use the table at the end of the instrument to report the title, year and author of the documents attached. 10. Attaching files to the questionnaire: please place all files to be attached in a single folder on your computer. Name the documents as follows: .doc (example: EML.doc). Then compress (ZIP) the files and attach the compressed file with the completed instrument to the email. If the total file size of the compressed file exceeds 7 MB, you can upload the documents in a protected file server called MedNet, which is managed by WHO. The procedure for doing this is very simple and please contact Mr Enrico Cinnella in WHO HQ, Geneva, (
[email protected]) to be granted access to MedNet and to receive instructions on how to upload files. You can also upload documents to the WHO Medicines Documentation server at http://hinfo.humaninfo.ro/medicinedocs/, though the documents will only appear on the Medicines Documentation site at the beginning of the following month. Pharmaceutical Sector Country Profile Questionnaire. Final Version.
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11. Manual for use of the questionnaire: the manual contains detailed instructions on the questionnaire, on where to find information and how to answer questions. Questions that may be particularly problematic are marked with the following icon:
12. Glossary: the glossary contains definitions for all key and/or problematic items in the instrument. It is highly recommended that you use the glossary, since exact definitions might differ between countries and institutions. The glossary is at the end of the file. When a question contains an item that is defined in the glossary, the terms will be marked in bold, underlined and written in blue font.
definition of "pharmaceutical technicians and assistants" is in the glossary
Instructions are available for this specific question
13. Respondents and acknowledgements: at the beginning of every section there are fields available to fill in details about the respondent for that particular section. It is also possible to enter the details of multiple respondents. At the end of the instrument please add a list of contributors who should be acknowledged. Provide their names and the main organization(s) they work for. 14. Endorsement of data: A formal endorsement needs to be signed by a senior official in the Ministry of Health before the completed questionnaire is sent back to WHO. The endorsement form is included in the pack of CD-ROM documents you have received from WHO. Please present the endorsement form to a senior official in the Ministry of Health for signature, and for obtaining permission to use and publish the data.
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15. Process of creating a country profile document: The data you will collect using this questionnaire can be used to develop a pharmaceutical sector country profile for the country. Examples of profiles are available on-line at http://www.who.int/medicines/areas/coordination/coordination_assessment/en/index1.html WHO has prepared a template profile (included in the CD) that can be easily used by countries and that will help presenting data in the form of tables, graphs and charts. Countries can use the generic template provided by WHO and add the information in the questionnaire. Below you can find an example of the template that shows how fields can be changed according to the specific responses provided by each country.
In each section of the questionnaire you will find some comment boxes that you can use to expand on the answer to one or more questions. The text of these comments can also be included in the profile in order to present the country situation in more detail. In the questionnaire you are also asked to indicate the source and date of each piece of information you provide; these should be used to develop bibliographic references for the profile. If you prefer, WHO can develop the narrative profile and the Organization will then share the document with the country, which will own/maintain the copyright for it and will be able to publish it as a national document.
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Section 0 General Info 0.01 Contact Info 0.01.01
Country (precoded)
Ethiopia-RV
0.01.02
Name coordinator
Dr. Ariaya Hymete
0.01.03
Address (Street, City)
Addis Ababa
0.01.04
Phone number
0911 33 50 99
0.01.05
Email address
[email protected]
0.01.06
Web address
0.01.07
Institution
Addis Ababa University
Pharmaceutical Sector Country Profile Questionnaire.
Section 1 Health and Demographic data 1.00 Respondent Information Section 1 1.00.01
Name of person responsible for filling out Survey section 1
1.00.02
Phone number
1.00.03
Email address
1.00.04
Other respondents for filling out this section
1.01 Demographic and Socioeconomic Indicators Core questions (click here for help) Year 1.01.01
Population, total (,000)
2010
Source
WHS
83,099
1.01.02
Population growth rate (Annual %)
2008 MOH
2.8
Ethiopia 1.01.03
Total Gross Domestic Product (GDP) (millions US$)
28,526.3
1.01.04
GDP growth (Annual %)
8.7
1.01.05C
GDP per capita (US$ current exchange rate)
343.28
1.01.06
Comments and References
2009
2008
2006
World Bank data World Bank data IMF
Supplementary questions (click here for help) Year 1.01.07S
Population < 15 years (% of total
44
Pharmaceutical Sector Country Profile Questionnaire.
2009
Source
WHS
population) 1.01.08S
Population > 60 years (% of total population)
2009 MOH
3
Ethiopia 1.01.09S
Urban population (% of total population)
2009
MOH Ethiopia
WHS
15
1.01.10S
Fertility rate, total (Births per woman)
5.3
2008
1.01.11S
Population living with less than $1.25/day (international PPP) (%)
39.04
2005 MOH
Ethiopia 1.01.12S
Population living below nationally defined poverty line (%)
1.01.13S
Income share held by lowest 20% of the population (% of national income)
1.01.14S
Adult literacy rate, 15+ years (% of relevant population)
1.01.15S
Comments and References
2000
World Bank data
2005
World Bank data
47
9.28
36
2008
WHS
1.02 Mortality and Causes of Death Core questions (click here for help) Year
Pharmaceutical Sector Country Profile Questionnaire. 14
Source
1.02.01
Life expectancy at birth for men (Years)
2009 MOH
53
Ethiopia 1.02.02
Life expectancy at birth for women (Years)
2009 MOH
55
Ethiopia 1.02.03
Infant mortality rate, between birth and age 1 (/1,000 live births)
69
2008
WHS
1.02.04
Under 5 mortality rate (/1,000 live births)
109
2008
WHS
1.02.05
Maternal mortality ratio (/100,000 live births)
2011 MOH
470
Ethiopia Yes
1.02.06
Please provide a list of top 10 diseases causing mortality
1.02.06.01
Disease 1
Pneumonia
1.02.06.02
Disease 2
Other or unspecified effects of external cases
1.02.06.03
Disease 3
Tuberculosis
1.02.06.04
Disease 4
Human immuno defficiency virus (HIV) disease
1.02.06.05
Disease 5
Anaemias
1.02.06.06
Disease 6
Other unspecified diseases of the circulatory system
1.02.06.07
Disease 7
Hypertension and related diseases
1.02.06.08
Disease 8
Malaria (Clinical without laboratory confirmation)
Pharmaceutical Sector Country Profile Questionnaire. 15
1.02.06.09
Disease 9
Malaria (confirmed with P. falciparum)
1.02.06.10
Disease 10
Road traffic injuries
1.02.07
Please provide a list of top 10 diseases causing morbidity
Yes
1.02.07.01
Disease 1
Malaria (clinical without laboratory confirmation)
1.02.07.02
Disease 2
Acute upper respiratory tract infections
1.02.07.03
Disease 3
Dyspepsia
1.02.07.04
Disease 4
Other unspecified infections and parasitic diseases
1.02.07.05
Disease 5
Pneumonia
1.02.07.06
Disease 6
Other or unspecified diseases of the respiratory system
1.02.07.07
Disease 7
Malaria (Confirmed with species other than P. falciparum)
1.02.07.08
Disease 8
Diarrhea with blood (dysentery)
1.02.07.09
Disease 9
Helmianthiasis
1.02.07.10
Disease 10
Diseases of musculoskeletal system and connective tissues
1.02.08
Comments and References
Health and health related indicators, FDRE, MOH 2001EC
Supplementary questions (click here for help) Year
Source
1.02.09S
Adult mortality rate for both sexes between 15 and 60 years (/1,000 population)
307
2008
WHS
1.02.10S
Neonatal mortality rate ( /1,000 live births)
39
2008
WHS
1.02.11S
Age-standardized mortality rate by non-communicable diseases (/100,000 population)
817
2008
WHS
1.02.12S
Age-standardized mortality rate by cardiovascular diseases (/100,000
2009
WHS
384
Pharmaceutical Sector Country Profile Questionnaire. 16
population) 1.02.13S
Age-standardized mortality rate by cancer ( /100,000 population)
1.02.14S
Mortality rate for HIV/AIDS (/100,000 population)
1.02.15S
Mortality rate for tuberculosis (/100,000 population)
64
2008
WHS
1.02.16S
Mortality rate for Malaria (/100,000 population)
51
2006
WHS
1.02.17S
Comments and References
142
2009
81
2007
Pharmaceutical Sector Country Profile Questionnaire. 17
WHS
WHS
Section 2 Health Services 2.00 Respondent Information Section 2 2.00.01
Name of person responsible for filling out this section of the instrument
2.00.02
Phone number
2.00.03
Email address
2.00.04
Other respondents for filling out this section
2.01 Health Expenditures Core questions (click here for help) Year
Source
2.01.01.01
Total annual expenditure on health (millions NCU)
8,450.44
2008
NHA data
2.01.01.02
Total annual expenditure on health (millions US$ average exchange rate)
880.25
2008
NHA data
2.01.02C
Total health expenditure as % of Gross Domestic Product
3.0
2.01.03.01C
Total annual expenditure on health per capita (NCU)
101.70
2.01.03.02C
Total annual expenditure on health per capita (US$ average exchange rate)
2.01.04.01
General government annual expenditure on health (millions NCU)
4,803.14
2008
NHA data
2.01.04.02
General government annual expenditure on health (millions US$ average exchange rate)
500.33
2008
NHA data
2.01.05
Government annual expenditure on health as percentage of total government budget (% of total government budget)
9.07
2008
NHA data
10.60
Pharmaceutical Sector Country Profile Questionnaire.
2.01.06C
Government annual expenditure on health as % of total expenditure on health (% of total expenditure on health)
56.84
2.01.07.01C
Annual per capita government expenditure on health (NCU)
57.8
2.01.07.02C
Annual per capita government expenditure on health (US$ average exchange rate)
6.02
2.01.08C
Private health expenditure as % of total health expenditure (% of total expenditure on health)
43.16
2.01.09
Population covered by a public health service or public health insurance or social health insurance, or other sickness funds of total population)
2.01.10
Population covered by private health insurance (% of total population)
2.01.11.01
Total pharmaceutical expenditure (millions NCU)
2,439.2
2006
FMOH
2.01.11.02
Total pharmaceutical expenditure (millions US$ current exchange rate)
289.7
2006
FMOH
2.01.12.01C
Total pharmaceutical expenditure per capita (NCU)
29.35
2.01.12.02C
Total pharmaceutical expenditure per capita (US$ current exchange rate)
3.49
2.01.13C
Pharmaceutical expenditure as a % of GDP (% of GDP)
1.01
2006
FMOH
2.01.14C
Pharmaceutical expenditure as a % of Health Expenditure (% of total health expenditure)
32.91
2.01.15.01
Total public expenditure on
232.62
2008
Pharmaceutical Sector Country Profile Questionnaire. 19
NHA data
pharmaceuticals (millions NCU) 2.01.15.02
Total public expenditure on pharmaceuticals (millions US$ current exchange rate)
27.6
2.01.16C
Share of public expenditure on pharmaceuticals as percentage of total expenditure on pharmaceuticals (%)
9.53
2.01.17.01C
Total public expenditure on pharmaceuticals per capita (NCU)
2.01.17.02C
Total public expenditure on pharmaceuticals per capita (US$ current exchange rate)
0.33
2.01.18.01
Total private expenditure on pharmaceuticals (millions NCU)
1,146.5
2006
FMOH
2.01.18.02
Total private expenditure on pharmaceuticals (millions US$ current exchange rate)
136.2
2006
FMOH
2.01.19
Comments and References
Drug financing in Ethiopia, FMOH, 2007
2.8
Supplementary questions (click for help) Year 2.01.20S
Social security expenditure as % of government expenditure on health (% of government expenditure on health)
2.01.21S
Market share of generic pharmaceuticals [branded and INN] by value (%)
2.01.22S
Annual growth rate of total pharmaceuticals market value (%)
2.01.23S
Annual growth rate of generic pharmaceuticals market value (%)
0.0
2008
Pharmaceutical Sector Country Profile Questionnaire. 20
Source
NHA data
2.01.24S
Private out-of-pocket expenditure as % of private health expenditure (% of private expenditure on health)
80.49
2008
NHA data
2.01.25S
Premiums for private prepaid health plans as % of total private health expenditure (% of private expenditure on health)
3.02
2008
NHA data
2.01.26S
Comments and References
2.02 Health Personnel and Infrastructure Core questions (click for help) Year 2.02.01
Total number of pharmacists licensed/registered to practice in your country
Source
2009 Health
492
indicator MOH 2.02.02C
Pharmacists per 10,000 population
2.02.03
Total number of pharmacists working in the public sector
2.02.04
Total number of pharmaceutical technicians and assistants
2.02.05
A strategic plan for pharmaceutical human resource development is in place in your country?
2.02.06
Total number of physicians
0.06
1,023
Yes
2007
Global Health Atlas
No
2009 Health
2,151
indicator MOH 2.02.07C
Physicians per 10,000 pop
Pharmaceutical Sector Country Profile Questionnaire. 21
0.26 2.02.08
Total number of nursing and midwifery personnel
2009 Health
20,109
indicator MOH 2.02.09C
Nurses and midwives per 10,000 pop
2.42
2.02.10
Total number of hospitals
195
2.02.11
Number of hospital beds per 10,000 pop
2.00
2.02.12
Total number of primary health care units and centers
13850
2.02.13
Total number of licensed pharmacies
2.02.14
Comments and References
2008
2009
2009
Health indicator MOH World Health Survey 2010 Health indicator MOH
Health and health related indicators, FDRE, MOH 2001EC
Supplementary questions (click here for help) Year
Source
2.02.15S
Starting annual salary for a newly registered pharmacist in the public sector (NCU)
2807
2010
MOH
2.02.16S
Total number of pharmacists who graduated (first degree) in the past 2 years in your country
226
2007
rad.aid.org
2.02.17S
Are there accreditation requirements for pharmacy schools?
Yes
No
2010
SOP
2.02.18S
Is the Pharmacy Curriculum regularly reviewed?
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 22
2.02.19S
Comments and References
www.rad.aid.org
Pharmaceutical Sector Country Profile Questionnaire. 23
Section 3 Policy issues 3.00 Respondent Information Section 4 3.00.01
Name of person responsible for filling out this section of the instrument
3.00.02
Phone number
3.00.03
Email address
3.00.04
Other respondents for filling out this section
3.01 Policy Framework Core questions (click here for help) Year
Source
3.01.01
National Health Policy exists. If yes, please write year of the most recent document in the "year" field.
Yes
No
1993
Health policy MOH
3.01.02
National Health Policy Implementation plan exists. If yes, please write the year of the most recent document in the "year"
Yes
No
1995
Health sector strategy MOH
3.01.03
Please provide comments on the Health policy and its implementation plan
The health policy was put forward in 1993 and its implementation is in progress and achievements are there as indicated in the HSDP III MTR
3.01.04
National Medicines Policy official document exists. If yes, please write the year of the most recent document in the "year" field.
Yes
No
2007
WHO level I
3.01.05
Group of policies addressing pharmaceuticals exist.
Yes
No
1993
Health policy MOH
3.01.06
National Medicines Policy covers the following components:
Yes
Pharmaceutical Sector Country Profile Questionnaire.
3.01.06.01
Selection of Essential Medicines
Yes
3.01.06.02
Medicines Financing
Yes
3.01.06.03
Medicines Pricing
Yes
3.01.06.04
Medicines Procurement
Yes
3.01.06.05
Medicines Distribution
Yes
3.01.06.06
Medicines Regulation
Yes
3.01.06.07
Pharmacovigilance
Yes
3.01.06.08
Rational Use of Medicines
Yes
3.01.06.09
Human Resource Development
Yes
3.01.06.10
Research
Yes
3.01.06.11
Monitoring and Evaluation
Yes
3.01.06.12
Traditional Medicine
Yes
3.01.07
National medicines policy implementation plan exists. If yes, please write year of the most recent document.
Yes
3.01.08
Policy or group of policies on clinical laboratories exist. If yes, please write year of the most recent document in the "year" field
Yes
No
3.01.09
National clinical laboratory policy implementation plan exists. If yes, please write year of the most recent document in the "year" field
Yes
No
3.01.10
Access to essential medicines/technologies as part of the fulfillment of the right to health, recognized in the constitution or national legislation?
Yes
No
No
Pharmaceutical Sector Country Profile Questionnaire. 25
2007
WHO level I
Health policy MOH
3.01.11
There are official written guidelines on medicines donations.
Yes
3.01.12
Is pharmaceutical policy implementation being regularly monitored/assessed?
Yes
3.01.12.01
Who is responsible for pharmaceutical policy monitoring?
Food, Medicines and Health Care Administration and control Authority of ethiopia
3.01.13
Is there a national good governance policy?
Yes
3.01.13.01
Multisectoral
Yes
3.01.13.02
For the pharmaceutical sector
Yes
3.01.13.03
Which agencies are responsible?
3.01.14
A policy is in place to manage and sanction conflict of interest issues in pharmaceutical affairs.
Yes
No
3.01.15
There is a formal code of conduct for public officials.
Yes
No
3.01.16
Is there a whistle-blowing mechanism allowing individuals to raise a concern about wrongdoing occurring in the pharmaceutical sector of your country (ombudsperson)?
Yes
No
3.01.16.01
Please describe:
3.01.17
Comments and References
No
2007
WHO level I
No
No
http://cnhde.ei.columbia.edu http://collections.infocollections.org
Pharmaceutical Sector Country Profile Questionnaire. 26
Section 4 Medicines Trade and Production 4.00 Respondent Information Section 4 4.00.01
Name of person responsible for filling out this section of the instrument
Mr. Abdrazak Omer
4.00.02
Phone number
0911 500813
4.00.03
Email address
[email protected]
4.00.04
Other respondents for filling out this section
4.01 Intellectual Property Laws and Medicines Core questions (click here for help) Year 4.01.01
Country is a member of the World Trade Organization
4.01.02
Legal provisions provide for granting of Patents on:
Yes
No
WTO
2007
WHO level I
2007
WHO level I
Yes
4.01.02.01
Pharmaceuticals
Yes
No
4.01.02.02
Laboratory supplies
Yes
No
4.01.02.03
Medical supplies
Yes
No
4.01.02.04
Medical equipment
Yes
No
4.01.03.01
Please provide name and address of the institution responsible for managing and enforcing intellectual property rights
Ethiopian Intelectual Property Office
4.01.03.02
Please provide URL
http://www.eipo.gov.et
4.01.04
National Legislation has been modified to implement the TRIPS Agreement
Yes
No
4.01.05
Current laws contain (TRIPS)
Yes
No
Source
P.O.Box 25322 Addis Ababa, Ethiopia
Pharmaceutical Sector Country Profile Questionnaire.
2010
flexibilities and safeguards 4.01.06
Country is eligible for the transitional period to 2016
4.01.07
Which of the following (TRIPS) flexibilities and safeguards are present in the national law?
Yes
No
2007 Yes
4.01.07.01
Compulsory licensing provisions that can be applied for reasons of public health
Yes
No
4.01.07.02
Bolar exception
Yes
No
4.01.08
Are parallel importing provisions present in the national law?
Yes
No
4.01.09
The country is engaged in initiatives to strengthen capacity to manage and apply intellectual property rights to contribute to innovation and promote public health
Yes
No
4.01.10
Are there legal provisions for data exclusivity for pharmaceuticals
Yes
No
4.01.11
Legal provisions exist for patent extension
Yes
No
4.01.12
Legal provisions exist for linkage between patent status and Marketing Authorization
Yes
No
4.01.13
Comments and References
WHO level I
2007
WHO level I
Year
Source
4.01.04 Country not a member of the WTO
4.02 Manufacturing Core questions (click here for help)
4.02.01
Number of licensed pharmaceutical manufacturers in the country
4.02.02
Country has manufacturing capacity
13
2004
2007 Yes
Pharmaceutical Sector Country Profile Questionnaire. 28
DACA
WHO level I
4.02.02.01
R&D to discover new active substances
Yes
No
Unknown
4.02.02.02
Production of pharmaceutical starting materials (APIs)
Yes
No
Unknown
4.02.02.03
Production of formulations from pharmaceutical starting material
Yes
No
Unknown
4.02.02.04
Repackaging of finished dosage forms
Yes
No
Unknown
4.02.03
Percentage of market share by value produced by domestic manufacturers (%)
4.02.04
Comments and References
http://www.daca.gov.et/statisticsnew.html
Supplementary questions (click here for help) Year 4.02.05S
Percentage of market share by volume produced by domestic manufacturers (%)
4.02.06S
Number of multinational pharmaceutical companies manufacturing medicines locally
4.02.07S
Number of manufacturers that are Good Manufacturing Practice (GMP) certified
4.02.08S
Comments and References
Pharmaceutical Sector Country Profile Questionnaire. 29
Source
Section 5 Medicines Regulation 5.00 Respondent Information Section 4 5.00.01
Name of person responsible for filling out this section of the instrument
5.00.02
Phone number
5.00.03
Email address
5.00.04
Other respondents for filling out this section
5.01 Regulatory Framework Core questions (click here for help) Year
Source
5.01.01
Are there legal provisions establishing the powers and responsibilities of the Medicines Regulatory Authority (MRA)?
Yes
No
2007
WHO level I
5.01.02
There is a Medicines Regulatory Authority
Yes
No
2007
WHO level I
5.01.03
If yes, please provide name and address of the Medicines regulatory authority
Food, medicine and health care administration and control of Ethiopia (FMHACA)
5.01.04
The Medicines Regulatory Authority is:
Yes
5.01.04.01
Part of MoH
Yes
5.01.04.02
Semi autonomous agency
Yes
5.01.04.03
Other (please specify)
5.01.05
What are the functions of the National Medicines Regulatory Authority?
Parastatal agency
Yes
Pharmaceutical Sector Country Profile Questionnaire. 30
5.01.05.01
Marketing authorization / registration
Yes
No
5.01.05.02
Inspection
Yes
No
5.01.05.03
Import control
Yes
No
5.01.05.04
Licensing
Yes
No
5.01.05.05
Market control
Yes
No
5.01.05.06
Quality control
Yes
No
5.01.05.07
Medicines advertising and promotion
Yes
No
5.01.05.08
Clinical trials control
Yes
No
5.01.05.09
Pharmacovigilance
Yes
No
5.01.05.10
Other: (please explain)
Also controls veterinary drugs and traditional herbal medicines
5.01.06
Number of the MRA permanent staff
2009
Health indicator MOH
5.01.06.01
Date of response
5.01.07
The MRA has its own website
5.01.07.01
- If yes, please provide MRA site address (URL)
5.01.08
The MRA receives external technical assistance
5.01.08.01
If yes, please describe:
5.01.09
The MRA is involved in harmonization/ collaboration initiatives
5.01.09.01
- If yes, please specify
5.01.10
An assessment of the medicines regulatory system has been conducted in the last five years.
Yes Web
No
2009
WHO
http://www.daca.gov.et/
Yes
No
Yes
No
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 31
2007
WHO level I
5.01.11
Medicines Regulatory Authority gets funds from regular budget of the government.
Yes
No
2010
WHS
5.01.12
Medicines Regulatory Authority is funded from fees for services provided.
Yes
No
2007
WHO level 1
5.01.13
Medicines Regulatory Authority receives funds/support from other sources
Yes
No
2007
WHO level 1
5.01.13.01
- If yes, please specify
5.01.14
Revenues derived from regulatory activities are kept with the Regulatory
Yes
No
2010
WHS
Yes
No
Year
Source
Authority 5.01.15
The Regulatory Authority is using a computerized information management system to store and retrieve information on registration, inspections, etc.
5.01.16
Comments and References
5.02 Marketing Authorization (Registration) Core questions (click here for help)
5.02.01
Legal provisions require a Marketing Authorization (registration) for all pharmaceutical products on the market
Yes
No
2007
WHO level I
5.02.02
Are there any mechanism for exception/waiver of registration?
Yes
No
2010
Procl. 661/2009 FDRE
5.02.03
Are there mechanisms for recognition of registration done by other
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 32
countries 5.02.03.01
If yes, please explain:
5.02.04
Explicit and publicly available criteria exist for assessing applications for Marketing Authorization of pharmaceutical products
Yes
No
5.02.05
Information from the prequalification programme managed by WHO is used for product registration
Yes
No
5.02.06
Number of pharmaceutical products registered in your country
5.02.07
Legal provisions require the MRA to make the list of registered pharmaceuticals with defined periodicity publicly available
5.02.07.01
If yes, how frequently updated
5.02.07.02
If yes, please provide updated list or URL *
5.02.08
5.02.09
5.02.10
2010 4000
DACA
Yes
No
2007
WHO level I
Medicines registration always includes the INN (International Nonproprietary Names)
Yes
No
2007
WHO level I
Legal provisions require the payment of a fee for Medicines Marketing Authorization (registration) applications
Yes
No
2007
FMOH/
Comments and References
http://www.daca.gov.et/statisticsnew.html
WHO
Survey on prices of medicines in Ethiopia, FMOH/WHO, 2007 Guidelines for registration of human drugs, DACA
Supplementary questions (click here for help) Year
Pharmaceutical Sector Country Profile Questionnaire. 33
Source
5.02.11S
Legal provisions require Marketing Authorization holders to provide information about variations to the existing Marketing Authorization
Yes
No
5.02.12S
Legal provisions require publication of a Summary of Product Characteristics (SPCs) of the medicines registered
Yes
No
5.02.13S
Legal provisions require the establishment of an expert committee involved in the marketing authorization process
Yes
No
2007
WHO level I
5.02.14S
Certificate for Pharmaceutical Products in accordance with the WHO Certification scheme is required as part of the Marketing Authorization application
Yes
No
2007
WHO level I
5.02.15S
Legal provisions require declaration of potential conflict of interests for the experts involved in the assessment and decision-making for registration
Yes
No
5.02.16S
Legal provisions allow applicants to appeal against MRAs decisions
Yes
No
2010
Procl. 661/2009
DACA
FDRE 5.02.17S
Registration fee - the amount per application for pharmaceutical product containing New Chemical Entity (NCE) (US$)
5.02.18S
Registration fee - the Amount per application for a generic pharmaceutical product (US$)
5.02.19S
Time limit for the assessment of a Marketing Authorization application (months)
1
5.02.20S
Comments & References
Guidelines for registration of human drugs, DACA
DACA
Pharmaceutical Sector Country Profile Questionnaire. 34
5.03 Regulatory Inspection Core Questions(click here for help)
5.03.01
Legal provisions exist allowing for appointment of government pharmaceutical inspectors
Yes
No
Year
Source
2010
Procl. 661/2009 FDRE
5.03.02
Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed
Yes
No
2010 Procl.
661/2009 FDRE 5.03.02.01
If yes, legal provisions exist requiring inspections to be performed
5.03.03
Inspection is a pre-requisite for licensing of:
Yes
No
2010 Yes
Procl. 661/2009 FDRE
5.03.03.01
Public facilities
Yes
No
5.03.03.02
Private facilities
Yes
No
5.03.04
Inspection requirements are the same for public and private facilities
Yes
No
5.03.05.01
Local manufactures are inspected for GMP compliance
Yes
No
2010 Proc.
661/2009 5.03.05.02
Private wholesalers are inspected
Yes
No
5.03.05.03
Retail distributors are inspected
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 35
5.03.05.04
Public pharmacies and stores are inspected
Yes
No
5.03.05.05
Pharmacies and dispensing points of health facilities are inspected
Yes
No
5.03.05.06
Please provide details on frequency of inspections for the different categories of facilities
Done at least once in a year and can be done when deemed necessary during the working hours.
5.03.06
Comments and References
Proclamation number 661/2009 of the Federal Democratic Republic of Ethiopia.
5.04 Import Control Core Questions (click here for help)
5.04.01
Legal provisions exist requiring authorization to import medicines
Yes
No
Year
Source
2010
Procl. 661/2009 FDRE
5.04.02
Legal provisions exist allowing the sampling of imported products for testing
Yes
No
2010
Procl. 661/2009 FDRE
5.04.03
Legal provisions exist requiring importation of medicines through authorized ports of entry
Yes
No
2010
Procl. 661/2009 FDRE
5.04.04
5.04.05
Legal provisions exist allowing inspection of imported pharmaceutical products at the authorized ports of entry
Yes
No
2010
Procl. 661/2009
Comments and References
Proclamation number 661/2009 of the Federal Democratic Republic of Ethiopia.
FDRE
5.05 Licensing
5.05.01
Legal provisions exist requiring
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 36
Year
Source
2007
WHO
manufacturers to be licensed 5.05.02
Legal provisions exist requiring both domestic and international manufacturers to comply with Good manufacturing Practices (GMP)
5.05.02.01
If no, please explain
5.05.03
level I Yes
No
DACA
GMP requirements are published by the government.
Yes
No
5.05.04
Legal provisions exist requiring importers to be licensed
Yes
No
2007
WHO level I
5.05.05
Legal provisions exist requiring wholesalers and distributors to be licensed
Yes
No
2007
WHO level I
5.05.06
Legal provisions exist requiring wholesalers and distributors to comply with Good Distributing Practices
Yes
No
2010
Procl. 661/2009
When filling in this part, please also fill in the relevant questions in the procurement and distribution section (Section 7) 5.05.07
National Good Distribution Practice requirements are published by the government
Yes
No
5.05.08
Legal provisions exist requiring pharmacists to be registered
Yes
No
FDRE 5.05.09
Legal provisions exists requiring private pharmacies to be licensed
Yes
No
2010
Procl. 661/2009 FDRE
5.05.10
Legal provision exist requiring public pharmacies to be licensed
Yes
No
2010
Procl. 661/2009 FDRE
Pharmaceutical Sector Country Profile Questionnaire. 37
5.05.11
National Good Pharmacy Practice Guidelines are published by the government
Yes
No
5.05.12
Legal provisions require the publication of a list of all licensed pharmaceutical facilities
Yes
No
5.05.13
Comments and References
Proclamation number 661/2009 of the Federal Democratic Republic of Ethiopia.
5.06 Market Control and Quality Control Core Questions (click here for help)
5.06.01
Legal Provisions for regulating the pharmaceutical market exist
Yes
No
5.06.02
Does a laboratory exist in the country for Quality Control testing?
Yes
No
Year
Source
2010
Procl. 661/2009 FDRE
5.06.02.01
If yes, is the laboratory part of the MRA?
Yes
No
5.06.02.02
Does the regulatory authority contract services elsewhere?
Yes
No
5.06.02.03
If yes, please describe
5.06.03
Is there any national laboratory accepted for collaboration with WHO prequalification Programme? Please describe.
5.06.04
Medicines are tested:
2010
Procl. 661/2009
s FDRE 5.06.04.01
For quality monitoring in the public sector (routine sampling in pharmacy stores and health facilities)
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 38
5.06.04.02
For quality monitoring in private sector (routine sampling in retail outlets)
Yes
No
5.06.04.03
When there are complaints or problem reports
Yes
No
5.06.04.04
For product registration
Yes
No
5.06.04.05
For public procurement prequalification
Yes
No
5.06.04.06
For public program products prior to acceptance and/or distribution
Yes
No
5.06.05
Samples are collected by government inspectors for undertaking post-marketing surveillance testing
Yes
No
5.06.06
How many Quality Control samples were taken for testing in the last two years?
5.06.07
Total number of samples tested in the last two years that failed to meet quality standards
5.06.08
Results of quality testing in past two years are publicly available
Yes
No
5.06.09
Comments and References
Proclamation number 661/2009 of the Federal Democratic Republic of Ethiopia.
2007
WHO level I
5.07 Medicines Advertising and Promotion Core Questions (click here for help) Year
Source
2007
WHO level I
5.07.01
Legal provisions exist to control the promotion and/or advertising of prescription medicines
Yes
5.07.02
Who is responsible for regulating, promotion and/or advertising of
Food, Medicine and Health Care Administration of Ethiopia
No
Pharmaceutical Sector Country Profile Questionnaire. 39
medicines? Please describe: 5.07.03
Legal provisions prohibit direct advertising of prescription medicines to the public
Yes
No
2007
WHO level I
5.07.04
Legal provisions require a preapproval for medicines advertisements and promotional materials
Yes
No
2007
WHO level I
5.07.05
Guidelines/Regulations exist for advertising and promotion of nonprescription medicines
Yes
No
2007
WHO level I
5.07.06
A national code of conduct exists concerning advertising and promotion of medicines by marketing authorization holders and is publicly available
Yes
No
5.07.06.01
If yes, the code of conduct applies to domestic manufacturers only, multinational manufacturers only, or both
Yes
No
Domestic only
Yes
Multinational only
Yes
Both
Yes
5.07.06.02
If yes, adherence to the code is voluntary
Yes
No
5.07.06.03
If yes, the code contains a formal process for complaints and sanctions
Yes
No
5.07.06.04
If yes, list of complaints and sanctions for the last two years is publicly available
Yes
No
5.07.07
Comments and References
Guidelines on the requirements for the registration of pharmaceutical manufacturers
Pharmaceutical Sector Country Profile Questionnaire. 40
DACA
5.08 Clinical trials Core Questions (click here for help)
5.08.01
Legal provisions exist requiring authorization for conducting Clinical Trials by the MRA
Yes
No
Year
Source
2010
Procl. 661/2009 FDRE
5.08.02
Legal provisions exist requiring the agreement by an ethics committee/ institutional review board of the Clinical Trials to be performed
Yes
No
DACA
5.08.03
Legal provisions exist requiring registration of the clinical trials into international/national/regional registry
Yes
No
DACA
5.08.04
Comments and References
Guidelines for conducting clinical trials in Ethiopia
Supplementary questions (click here for help) Year
Source
5.08.05S
Legal provisions exist for GMP compliance of investigational products
Yes
No
DACA
5.08.06S
Legal provisions require sponsor, investigator to comply with Good Clinical Practices (GCP)
Yes
No
DACA
5.08.07S
National GCP regulations are published by the Government.
Yes
No
5.08.08S
Legal provisions permit inspection of facilities where clinical trials are performed
Yes
No
5.08.09S
Comments and References
Guidelines for conducting clinical trials in Ethiopia
5.09 Controlled Medicines
Pharmaceutical Sector Country Profile Questionnaire. 41
DACA
Core Questions (click here for help) Date 5.09.01
The country has adopted the following conventions:
Source
Yes
5.09.01.01
Single Convention on Narcotic Drugs, 1961
Yes
No
1965
Internatio nal Narcotics Control Board, 2010
5.09.01.02
The 1972 Protocol amending the Single Convention on Narcotic Drugs, 1961
Yes
No
1994
Internation al Narcotics Control Board, 2010
5.09.01.03
Convention on Psychotropic Substances 1971
Yes
No
1980
Internation al Narcotics Control Board, 2010
5.09.01.04
United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988
Yes
No
1990
Internation al Narcotics Control Board, 2010
5.09.02
Laws for the control of narcotic and psychotropic substances, and precursors exist
Yes
No
2010
Procl. 661/2009 FDRE
5.09.03
Annual consumption of Morphine (mg/capita)
5.09.04
Comments and References
0.000285
2009
Internation al Narcotics Control Board, 2010
Supplementary questions (click here for help) Year
Pharmaceutical Sector Country Profile Questionnaire. 42
Source
5.09.05S
The legal provisions and regulations for the control of narcotic and psychotropic substances, and precursors have been reviewed by a WHO International Expert or Partner Organization to assess the balance between the prevention of abuse and access for medical need
5.09.05.01S
If yes, year of review
5.09.06S
Annual consumption of Fentanyl (mg/capita)
5.09.07S
Annual consumption of Pethidine (mg/capita)
5.09.08S
Annual consumption of Oxycodone (mg/capita)
5.09.09S
Annual consumption of Hydrocodone (mg/capita)
5.09.10S
Annual consumption of Phenobarbital (mg/capita)
5.09.11S
Annual consumption of Methadone (mg/capita)
5.09.12S
Comments and References
Yes
No
0.161312
Unknown
2009
Internation al Narcotics Control Board, 2010
5.10 Pharmacovigilance Core Questions (click here for help)
5.10.01
There are legal provision in the Medicines Act that provides for pharmacovigilance activities as part of the MRA mandate
Yes
No
5.10.02
Legal provisions exist requiring the Marketing Authorization holder to
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 43
Year
Source
1993
Drug policy, FMOH
continuously monitor the safety of their products and report to the MRA 5.10.03
Legal provisions about monitoring Adverse Drug Reactions (ADR) exist in your country
Yes
No
DACA
5.10.04
A national pharmacovigilance centre linked to the MRA exists in your country
Yes
No
DACA
5.10.04.01
If a national pharmacovigilance centre exists in your country, how many staff does it employ fulltime
5.10.04.02
If a national pharmacovigilance center exists in your country, an analysis report has been published in the last two years.
Yes
No
5.10.04.03
If a national pharmacovigilance center exists in your country, it publishes an ADR bulletin
Yes
No
5.10.05
An official standardized form for reporting ADRs is used in your country
Yes
No
5.10.06
A national Adverse Drug Reactions database exists in your country
Yes
No
5.10.07
How many ADR reports are in the database?
5.10.08
How many reports have been submitted in the last two years?
5.10.09
Are ADR reports sent to the WHO database in Uppsala?
Yes
No
5.10.09.01
If yes, number of reports sent in the last two years
5.10.10
Is there a national ADR or pharmacovigilance advisory
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 44
DACA
DACA
committee able to provide technical assistance on causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication? 5.10.11
Is there a clear communication strategy for routine communication and crises communication?
Yes
No
5.10.12
In the absence of a national pharmacovigilance system, ADRs are monitored in at least one public health program (for example TB, HIV, AIDS)?
Yes
No
5.10.13
Please describe how you intend to enhance the Pharmacovigilance system
5.10.14
Comments and References
ADRmonitoring and promotion control division, DACA Is responsible to control the activity. Guidelines for Adverse Drug Reaction reporting, DACA
Supplementary questions (click here for help) Year 5.10.15S
Feedback is provided to reporters
Yes
No
5.10.16S
The ADR database is computerized
Yes
No
5.10.17S
Medication errors (MEs) are reported
Yes
No
5.10.18S
How many MEs are there in the ADRs database?
5.10.19S
There is a risk management plan presented as part of product dossier submitted for Marketing Authorization?
Yes
No
5.10.20S
In the past two years, who has reported ADRs?
Yes
Pharmaceutical Sector Country Profile Questionnaire. 45
Source
5.10.20.01S
Doctors
Yes
5.10.20.02S
Nurses
Yes
5.10.20.03S
Pharmacists
Yes
5.10.20.04S
Consumers
Yes
5.10.20.05S
Pharmaceutical Companies
Yes
5.10.20.06S
Others, please specify whom
5.10.21S
Was there any regulatory decision based on local pharmacovigilance data in the last 2 years?
Yes
No
5.10.22S
Are there training courses in pharmacovigilance?
Yes
No
5.10.22.01S
If yes, how many people have been trained in the last two years?
5.10.23S
Comments and References
Trainings on pharmacovigilance has been organized by DACA, EPA and others but there is on document indicating the number of trained professionals.
Pharmaceutical Sector Country Profile Questionnaire. 46
Section 6 Medicines Financing 6.00 Respondent Information Section 5 6.00.01
Name of person responsible for filling out this section of the instrument
6.00.02
Phone number
6.00.03
Email address
6.00.04
Other respondents for this sections
w/o Senait Seyoum Tel. 0911448790
6.01 Medicines Coverage and Exemptions Core Questions (click here for help) Year 6.01.01
Do the followings receive medicines free of charge:
Yes
6.01.01.01
Patients who cannot afford them
Yes
No
6.01.01.02
Children under 5
Yes
No
6.01.01.03
Pregnant women
Yes
No
6.01.01.04
Elderly persons
Yes
No
6.01.01.05
Please describe/explain your yes answers for questions above
6.01.02
Is there a public health system or social health insurance scheme or public programme providing medicines free of charge for :
Yes
6.01.02.01
All medicines included in the EML
Yes
No
6.01.02.02
Any non-communicable diseases
Yes
No
6.01.02.03
Malaria medicines
Yes
No
6.01.02.04
Tuberculosis medicines
Yes
No
6.01.02.05
Sexually transmitted diseases
Yes
No
Pharmaceutical Sector Country Profile Questionnaire.
Source
2007
WHO level I
2007
WHO level I
medicines 6.01.02.06
HIV/AIDS medicines
Yes
No
6.01.02.07
Expanded Program on Immunization (EPI) vaccines
Yes
No
6.01.02.08
If others, please specify
6.01.02.09
Please describe/explain your yes answers for questions above
6.01.03
Does a national health insurance, social insurance or other sickness fund provide at least partial medicines coverage?
Yes
No
6.01.03.01
Does it provide coverage for medicines that are on the EML for inpatients
Yes
No
6.01.03.02
Does it provide coverage for medicines that are on the EML for outpatients
Yes
No
6.01.03.03
Please describe the medicines benefit of public/social insurance schemes
6.01.04
Do private health insurance schemes provide any medicines coverage?
Yes
No
6.01.04.01
If yes, is it required to provide coverage for medicines that are on the EML?
Yes
No
6.01.05
Comments and References
Drug financing in Ethiopia, FMOH, 2007
2007
FMOH
Year
Source
2007
WHO level I
6.02 Patients Fees and Copayments Core Questions (click here for help)
6.02.01
In your health system, at the point of delivery, are there any copayment/fee requirements for
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 48
consultations 6.02.02
In your health system, at the point of delivery, are there any copayment/fee requirements for medicines
Yes
No
2007
WHO level I
6.02.03
In practice, (even though this may be contrary to regulations) is revenue from fees or sales of medicines sometimes used to pay the salaries or supplement the income of public health personnel in the same facility?
Yes
No
2007
WHO level I
6.02.03.01
Please describe the patient fees and copayments system
6.02.04
Comments and References
Year
Source
2007
WHO level I
2007
WHO level 1
6.02.02 Flat fees for medicines apply
6.03 Pricing Regulation for the Private Sector Core Questions (click here for help)
6.03.01
Are there legal or regulatory provisions affecting pricing of medicines
Yes
No
6.03.01.01
If yes, are the provisions aimed at Manufacturers
Yes
No
6.03.01.02
If yes, are the provisions aimed at Wholesalers
Yes
No
6.03.01.03
If yes, are the provisions aimed at Retailers
Yes
No
6.03.01.04
Please explain the positive answers above: (explain scope of provisions i.e generics vs. originator or subsets of medicines, EML etc.)
6.03.02
Government runs an active national medicines price monitoring system for retail prices
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 49
6.03.03
Regulations exists mandating that retail medicine price information should be publicly accessible
6.03.03.01
-if yes, please explain how the information is made publically available
6.03.04
Comments and References
Yes
No
2007
WHO level I
Year
Source
6.04 Prices, Availability and Affordability Core Questions (click here for help)
6.04.01-04
Please state if a medicines price survey using the WHO/HAI methodology has been conducted in the past 5 years in your country.
Yes
No
Unknown
If yes, please indicate the year of the survey and use the results to fill in this table If no, but other surveys on medicines prices and availability have been conducted, please do not use them to fill in this section, but rather use the comment box to write some of the results and attach the report to the questionnaire Public patient
Private patient
Orig
6.04.01.01
6.04.01.03
LPG
6.04.01.02
6.04.01.04
52.9
88
6.04.02.01
6.04.02.03
Basket Of key medicines Availability (one or both of)
Mean (%)
Median (%)
Public procurement
Orig
0
Pharmaceutical Sector Country Profile Questionnaire. 50
6.04.02.02
LPG
76.5
Price
Median Price Ratio
Orig
6.04.03.01
6.04.03.03
6.04.02.04
96
6.04.03.05 11.5
LPG
6.04.03.02
6.04.03.04
0.61
1.35
6.04.03.06
2.25
Affordability Days’ wages of the lowest paid govt worker for standard treatment
Number of days’ wages
6.04.04.01
Orig
7.9 LPG
with co-trimoxazole for a child respiratory infection
6.04.05
6.04.04.03
Comments and References
6.04.04.02
6.04.04.04
0.3
0.6
Source WHO/HAI Surveys of medicine pricing, availability and affordability
6.05 Price Components and Affordability Core Questions (click here for help) Year 6.05.01
Please state if a survey of medicines price components has been conducted in the past 5 years in your country
6.05.02
Median cumulative percentage markup between Manufacturer Selling Price (MSP)/ Cost Insurance and Freight (CIF) price and final medicine price for a basket of key medicines in the public sector (Median %
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 51
Unknown
Source
contribution) 6.05.03
Median cumulative percentage markup between MSP/CIF price and final medicine price for a basket of key medicines in the private sector (Median % contribution)
6.05.04
Comment and References
Supplementary questions (click here for help) 6.05.05S
Median percentage contribution of MSP/CIF to final medicine price for a basket of key medicines in the public sector (Median % contribution)
6.05.06S
Median percentage contribution of MSP/CIF to final medicine price for a basket of key medicines in the private sector (Median % contribution)
6.05.07S
Median manufacturer selling price (CIF) as percent of final medicine price for a basket of key medicines (%)
6.05.08S
Median wholesaler selling price as percent of final medicine price for a basket of key medicines (%)
6.05.09S
Median pharmacist mark-up or dispensing fee as percent of retail price for a basket of key medicines (%)
6.05.10S
Median percentage contribution of the wholesale mark-up to final medicine price for a basket of key medicines (in the public and private sectors) (%)
6.05.11S
Median percentage contribution of the retail mark-up to final medicine price for a basket of key medicines (in the public and private sectors) (%)
Pharmaceutical Sector Country Profile Questionnaire. 52
6.05.12S
Comment and References
6.06 Duties and Taxes on Pharmaceuticals (Market) Core Questions (click here for help) Year
Source
6.06.01
There are duties on imported active pharmaceutical ingredients (APIs)
Yes
No
2007
WHO level I
6.06.02
There are duties on imported finished products
Yes
No
2007
WHO level I
6.06.03
VAT (value-added tax) or any other tax is levied on finished pharmaceuticals products
Yes
No
2010
Customs office
6.06.04
There are provisions for tax exceptions or waivers for pharmaceuticals and health products
Yes
No
2010
Cusetoms office
6.06.05
Please specify categories of pharmaceuticals on which the taxes are applied and describe the exemptions and waivers that exist
products such recin and pharmaceutical wastes are levied 15% VAT
6.06.06
Comments and References
VAT is levied only on some products such as pharmaceutical left overs.
Supplementary questions (click here for help) Year 6.06.07S
Duty on imported active pharmaceutical ingredients, APIs (%)
6.06.08S
Duty on imported finished products (%)
6.06.09S
VAT on pharmaceutical products (%)
6.06.10S
Comments and References
Pharmaceutical Sector Country Profile Questionnaire. 53
Source
Section 7 Pharmaceutical procurement and distribution 7.00 Respondent Information Section 6 7.00.01
Name of person responsible for filling out this section of the instrument
7.00.02
Phone number
7.00.03
Email address
7.00.04
Other respondents for filling out this section
7.01 Public Sector Procurement Core Questions (click here for help) Date 7.01.01
Public sector procurement is:
Yes
7.01.01.01
Decentralized
Yes
7.01.01.02
Centralized and decentralized
Yes
7.01.01.03
Please describe
7.01.02
If public sector procurement is wholly or partially centralized, it is under the responsibility of a procurement agency which
Yes
is: 7.01.02.01
Part of MoH
Yes
No
7.01.02.02
Semi-Autonomous
Yes
No
7.01.02.03
Autonomous
Yes
No
Pharmaceutical Sector Country Profile Questionnaire.
Source
7.01.02.04
A government procurement agency which procures all public goods
Yes
No
7.01.03
Public sector requests for tender documents are publicly available
Yes
No
7.01.04
Public sector tender awards are publicly available
Yes
No
7.01.05
Procurement is based on prequalification of suppliers
Yes
No
7.01.05.01
If yes, please describe how it works
7.01.06
Comments and References
http://sitersources.world bank.org
Supplementary questions (click here for help)
7.01.07S
Is there a written public sector procurement policy?. If yes, please write the year of approval in the "year" field
Yes
No
7.01.08S
Are there legal provisions giving priority in public procurement to goods produced by local manufacturers?
Yes
No
7.01.09S
The key functions of the procurement unit and those of the tender committee are clearly separated
Yes
No
7.01.10S
A process exists to ensure the quality of products procured
Yes
No
7.01.10.01S
If yes, the quality assurance process includes pre-qualification of products and suppliers
Yes
No
7.01.10.02S
If yes, explicit criteria and procedures exist for prequalification of suppliers
Yes
No
7.01.10.03S
If yes, a list of pre-qualified suppliers and products is publicly
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 55
Year
Source
2007
WHO level I
available 7.01.11S
List of samples tested during the procurement process and results of quality testing are available
7.01.12S
Which of the following tender methods are used in public sector procurement:
Yes
No
2007 Yes
7.01.12.01S
National competitive tenders
Yes
No
7.01.12.02S
International competitive tenders
Yes
No
7.01.12.03S
Direct purchasing
Yes
No
7.01.13S
Comments and References
WHO level I
7.02 Public Sector Distribution Core Questions (click here for help) Year 7.02.01
The government supply system department has a Central Medical Store at National Level
Yes
7.02.02
Number of public warehouses in the secondary tier of public distribution (State/Regional/Provincial)
8
7.02.03
There are national guidelines on Good Distribution Practices (GDP)
Yes
No
7.02.04
There is a licensing authority that issues GDP licenses
Yes
No
7.02.04.01
If a licensing authority exists, does it accredit public distribution facilities?
Yes
No
No
Pharmaceutical Sector Country Profile Questionnaire. 56
Source
2009
World bank
2009
World bank
7.02.05
List of GDP certified warehouses in the public sector exists
Yes
No
7.02.06
List of GDP certified distributors in the public sector exists
Yes
No
7.02.07
Comments and References
Ethiopia, Improving Health Systems, Public Sector Healthcare supply Chain Strategic Network Analysis and Design, 2009, The World Bank http://www.ghtechproject.com
Supplementary questions (click here for help) Year
7.02.08S
Which of the following processes is in place at the Central Medical Store:
Source
Yes
7.02.08.01S
Forecasting of order quantities
Yes
No
7.02.08.02S
Requisition/Stock orders
Yes
No
7.02.08.03S
Preparation of picking/packing slips
Yes
No
7.02.08.04S
Reports of stock on hand
Yes
No
7.02.08.05S
Reports of outstanding order lines
Yes
No
7.02.08.06S
Expiry dates management
Yes
No
7.02.08.07S
Batch tracking
Yes
No
7.02.08.08S
Reports of products out of stock
Yes
No
7.02.09S
Percentage % availability of key medicines at the Central Medical Store
73.3
7.02.10S
Average stock-out duration for a basket of medicines at the Central Medical Store, in days
61.1
7.02.11S
Routine Procedure exists to track the expiry dates of medicines at the Central Medical Store
Yes
2010
No
Pharmaceutical Sector Country Profile Questionnaire. 57
WHO Level II Survey
7.02.12S
The Public Central Medical Store is GDP certified by a licensing authority
Yes
No
7.02.13S
The Public Central Medical Store is ISO certified
Yes
No
7.02.14S
The second tier public warehouses are GDP certified by a licensing authority
Yes
No
7.02.15S
The second tier public warehouses are ISO certified
Yes
No
7.02.16S
Comments and References
WHO Level II survey 2010 data that is not yet made public.
7.03 Private Sector Distribution Core Questions (click here for help)
7.03.01
Legal provisions exist for licensing wholesalers in the private sector
Yes
No
Year
Source
2010
Procl. 661/2009 FDRE
7.03.02
Legal provisions exist for licensing distributors in the private sector
Yes
No
2010
Procl. 661/2009 FDRE
7.03.03
List of GDP certified wholesalers in the private sector exists
Yes
No
7.03.04
List of GDP certified distributors in the private sector exists
Yes
No
7.03.05
Comments and References
Proclamation No 661/2009, FMOH, Ethiopia directive for issuance of certificate of compitence for importers and wholesalers.
Pharmaceutical Sector Country Profile Questionnaire. 58
Section 8 Selection and rational use 8.00 Respondent Information Section 7 8.00.01
Name of person responsible for filling out this section of the instrument
8.00.02
Phone number
8.00.03
Email address
8.00.04
Other respondents for filling out this section
8.01 National Structures Core Questions (click here for help) Year 8.01.01
8.01.01.01
National essential medicines list (EML) exists. If yes, please write year of last update of EML in the "year" field
If yes, number of medicines on the EML (no. of INN)
Yes
No
Source
2010 DACA
345
8.01.01.02
If yes, there is a written process for selecting medicines on the EML
Yes
No
8.01.01.03
If yes, the EML is publicly available
Yes
No
8.01.01.04
If yes, is there any mechanism in place to align the EML with the Standard Treatment Guidelines (STG)
Yes
No
8.01.02
National Standard Treatment Guidelines (STGs) for most common illnesses are produced/endorsed by the MoH. If yes, please insert year of last
Yes
No
Pharmaceutical Sector Country Profile Questionnaire.
2010 DACA
update of STGs in the "year" field 8.01.03
8.01.04
8.01.05
8.01.06
STGs specific to Primary care exist. Please use the "year" field to write the year of last update of primary care guidelines
Yes
STGs specific to Secondary care (hospitals) exists. Please use the "year" field to write the year of last update of secondary care STGs.
Yes
STGs specific to Paediatric conditions exist. Please use the "year" field to write the year of last update of paediatric condition STGs
Yes
% of public health facilities with copy of EML (mean)- Survey data
8.3
No
2010 DACA
No
2010 DACA
No
2010 DACA
2010
WHO level I
8.01.07
% of public health facilities with copy of STGs (mean)- Survey data
2010 19.4
WHO
level I 8.01.08
A public or independently funded national medicines information centre provides information on medicines to prescribers, dispensers and consumers
Yes
No
8.01.09
Public education campaigns on rational medicine use topics have been conducted in the previous two years
Yes
No
8.01.10
A survey on rational medicine use has been conducted in the previous two years
Yes
No
2007
Pharmaceutical Sector Country Profile Questionnaire. 60
WHO level I
8.01.11
A national programme or committee (involving government, civil society, and professional bodies) exists to monitor and promote rational use of medicines
Yes
No
2007
WHO level I
8.01.12
A written National strategy exists to contain antimicrobial resistance. If yes, please write year of last update of the strategy in the "year" field
Yes
No
2007
WHO level I
8.01.13
Comments and References
Year
Source
2010
DACA
2007
WHO level I
WHO level I
Supplementary questions (click here for help)
8.01.14S
The Essential Medicines List (EML) includes formulations specific for children
Yes
No
8.01.15S
There are explicitly documented criteria for the selection of medicines in the EML
Yes
No
8.01.16S
There is a formal committee or other equivalent structure for the selection of products on the National EML
Yes
No
8.01.16.01S
If yes, conflict of interest declarations are required from members of national EML committee
Yes
No
8.01.17S
National medicines formulary exists
Yes
No
2007
8.01.18S
Is there a funded national intersectoral task force to coordinate the promotion of appropriate use of antimicrobials and prevention of spread of infection?
Yes
No
2007
8.01.19S
A national reference laboratory/or any other institution has responsibility for coordinating
Yes
No
2007
Pharmaceutical Sector Country Profile Questionnaire. 61
WHO level I
epidemiological surveillance of antimicrobial resistance 8.01.20S
Comments and References
8.02 Prescribing Core Questions (click here for help) Year 8.02.01
Legal provisions exist to govern the licensing and prescribing practices of prescriber
Yes
No
Source
2010 Proc.
661/2009 8.02.02
Legal provisions exist to restrict dispensing by prescribers
Yes
No
2010
Proc. 661/2009
8.02.03
Do prescribers in the private sector dispense medicines?
Yes
No
2010
Proc. 661/2009
8.02.04
Regulations require hospitals to organize/develop Drug and Therapeutics Committees (DTCs)
Yes
No
8.02.05
Do more than half of referral hospitals have a DTC?
Yes
No
Unknown
8.02.06
Do more than half of general hospitals have a DTC?
Yes
No
Unknown
2007
WHO level I
8.02.07
Do more than half of regions/provinces have a DTC?
Yes
No
Unknown
2007
WHO level I
8.02.08
The core medical training curriculum includes components on:
2007
WHO level I
2007
Yes
8.02.08.01
Concept of EML
Yes
No
8.02.08.02
Use of STGs
Yes
No
8.02.08.03
Pharmacovigilance
Yes
No
Pharmaceutical Sector Country Profile Questionnaire. 62
2007
WHO level I
WHO level I
8.02.08.04
Problem based pharmacotherapy
Yes
No
8.02.09
Mandatory continuing education that includes pharmaceutical issues is required for doctors (see physician)
Yes
No
8.02.10
Mandatory continuing education that includes pharmaceutical issues is required for nurses
Yes
No
8.02.11
Mandatory continuing education that includes pharmaceutical issues is required for paramedical staff
Yes
No
8.02.12
Prescribing by INN name is obligatory in:
2007
WHO level I
2007
WHO level I
2007
WHO level I
Yes
8.02.12.01
Public sector
Yes
No
8.02.12.02
Private sector
Yes
No
8.02.13
Average number of medicines prescribed per patient contact in public health facilities (mean)
2010 WHO
2.01
level II 8.02.14
% of medicines prescribed in outpatient public health care facilities that are in the national EML (mean)
2010 WHO
98.3
level II 8.02.15
% of medicines in outpatient public health care facilities that are prescribed by INN name (mean)
8.02.16
% of patients in outpatient public health care facilities receiving antibiotics (mean)
87.9
2010
WHO level II
2010 WHO
60.0
level II
Pharmaceutical Sector Country Profile Questionnaire. 63
8.02.17
% of patients in outpatient public health care facilities receiving injections (mean)
2010 WHO
23.3
level II 8.02.18
% of prescribed drugs dispensed to patients (mean)
8.02.19
% of medicines adequately labeled in public health facilities (mean)
86.0
2010
WHO level II
2010 WHO
87.0
level II 8.02.20
Comments and References
8.02.05 - 8.02.07 a FEW - exact proportion unknown
Supplementary questions (click here for help) Year 8.02.21S
A professional association code of conduct exists governing professional behaviour of doctors
Yes
No
8.02.22S
A professional association code of conduct exists governing professional behaviour of nurses
Yes
No
8.02.23S
Diarrhoea in children treated with Oral Rehydration Solution (ORS) (%)
70.9
8.02.24S
Comments and References
http://www.ema.org.et
Source
2010
EMA
2010
WHO level II
http://www.ena.org.et
8.03 Dispensing Core Questions (click here for help) Year 8.03.01
Legal provisions exist to govern dispensing practices of pharmaceutical personnel
Yes
No
2010
Pharmaceutical Sector Country Profile Questionnaire. 64
Source
Proc. 661/2009
8.03.02
The basic pharmacist training curriculum includes components on:
2007
WHO level I
Yes
8.03.02.01
Concept of EML
Yes
No
8.03.02.02
Use of STGs
Yes
No
8.03.02.03
Drug Information
Yes
No
8.03.02.04
Clinical pharmacology
Yes
No
8.03.02.05
Medicines supply management
Yes
No
8.03.03
Mandatory continuing education that includes rational use of medicines is required for pharmacists
Yes
No
2007
WHO level I
8.03.04
Generic substitution at the point of dispensing in public sector facilities is allowed
Yes
No
2007
WHO level I
8.03.05
Generic substitution at the point of dispensing in private sector facilities is allowed
Yes
No
2007
WHO level I
8.03.06
In practice, (even though this may be contrary to regulations) are antibiotics sometimes sold overthe-counter without any prescription?
Yes
No
Unknown
2007
WHO level I
8.03.07
In practice, (even though this may be contrary to regulations) are injections sometimes sold over-thecounter without any prescription?
Yes
No
Unknown
2007
WHO level I
8.03.08
Comments and References
http://www.epaethiopia.org
Supplementary questions (click here for help) Year 8.03.09S
A professional association code of conduct exists governing professional behaviour of
Yes
No
2006
Pharmaceutical Sector Country Profile Questionnaire. 65
Source
EPA
pharmacists 8.03.10S
In practice, (even though this may be contrary to regulations) do the following groups of staff sometimes prescribe prescription-only medicines at the primary care level in the public sector?
2007 Yes
8.03.10.01S
Nurses
Yes
No
Unknown
8.03.10.02S
Pharmacists
Yes
No
Unknown
8.03.10.03S
Paramedics
Yes
No
Unknown
8.03.10.04S
Personnel with less than one month training
Yes
No
Unknown
8.03.11S
Comments and References
Standard treatment guideling for health centers, FMOH
Pharmaceutical Sector Country Profile Questionnaire. 66
WHO level I
Section 9 Household data/access 9.00 Respondent Information section 8 9.00.01
Name of person responsible for filling out this section of the instrument
9.00.02
Phone number
9.00.03
Email address
9.00.04
Other respondents for filling out this section
9.01 Data from Household Surveys Core Questions (click here for help) Year
Source
9.01.01
What household surveys have been undertaken in the past 5 years to assess access to medicines?
9.01.02
Adults with acute condition in twoweek recall period who took all medicines prescribed by an authorized prescriber (%)
85.1
2003
WHS
9.01.03
Adults with acute conditions not taking all medicines because they cannot afford them (%)
27.8
2003
WHS
9.01.04
Adults (from poor households) with an acute health condition in twoweek recall period who took all medicines prescribed by an authorized prescriber (%)
92.6
2003
WHS
9.01.05
Adults (from poor households) with an acute condition in two-week recall period who did not take all medicines because they cannot afford them (%)
20.9
2003
WHS
Pharmaceutical Sector Country Profile Questionnaire.
9.01.06
Adults with chronic conditions taking all medicines prescribed by an authorized prescriber (%)
77.5
2003
WHS
9.01.07
Adults (from poor households) with chronic conditions not taking all medicines because they cannot afford them (%)
90.4
2003
WHS
9.01.08
Adults (from poor households) with chronic conditions who usually take all medicines prescribed by an authorized prescriber (%)
77.1
2003
WHS
9.01.09
Children (from poor households) with an acute condition in two-week recall period who took all medicines prescribed by an authorized prescriber (%)
91.9
2003
WHS
9.01.10
Percentage of people that obtained the medicines prescribed in the 15 days before the interview (%)
9.01.11
People that obtained prescribed medicines for free in the 15 days before the interview (%)
9.01.12
Comments and References
Supplementary questions (click here for help) Year
Source
9.01.13S
Adults with acute conditions not taking all medicines because the medicines were not available (%)
63.3
2003
WHS
9.01.14S
Adults with chronic conditions not taking all medicines because they cannot afford them (%)
58.9
2003
WHS
9.01.15S
Adults with chronic conditions not taking all medicines because the medicines were not available (%)
38.3
2003
WHS
9.01.16S
Children with acute conditions taking all medicines prescribed by
85.9
2003
WHS
Pharmaceutical Sector Country Profile Questionnaire. 68
an authorized prescriber (%) 9.01.17S
Children with acute conditions not taking all medicines because they cannot afford them (%)
42.2
2003
WHS
9.01.18S
Children with acute conditions not taking all medicines because the medicines were not available (%)
50.2
2003
WHS
9.01.19S
Children (from poor households) with acute conditions not taking all medicines because they cannot afford them (%)
26.9
2003
WHS
9.01.20S
Comments and References
Pharmaceutical Sector Country Profile Questionnaire. 69
Glossary
Key Documents to be attached
Document
Exact title
Author
National Medicines Policy (NMP) NMP implementation plan National Medicines Act National pharmaceutical human resources report or strategic plan Latest report on the national pharmaceutical market (any source) National Pharmacovigilance Centre report (including Adverse Drug Reaction, ADR, analysis report in the last two years) National pharmaceutical legislation for regulation Annual report of quality control laboratories Annual report of national regulatory authority Legal provisions on medicines price regulations Medicines procurement policy National Essential Medicines List (EML) National Standard Treatment Guidelines (STGs) National Strategy for antimicrobial resistance Pharmaceutical Sector Country Profile Questionnaire. 70
Publisher
Year
File name
Glossary Any other medicines pricing/availability surveys, household surveys, and rational use surveys than the ones used to prefill in the instrument.
Pharmaceutical Sector Country Profile Questionnaire. 71
Glossary
Pharmaceutical Sector Country Profile Questionnaire. 72
